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The Global Health Regulatory Requirements Database is a unique resource developed by the Global Health Technologies Coalition (GHTC)’s Global Health Regulatory Team at PATH. A member site of The Global Health Network, the database is designed to help researchers and regulatory affairs professionals access information they need to develop effective strategies for gaining approval to conduct clinical trials and market products.
Currently featuring 17 countries in Africa, Asia, and Latin America, the database provides consolidated access to country-level regulatory requirements. This includes:
- Contact information for national regulatory authority representatives.
- Overview of clinical trial requirements, including data requirements, costs, and estimated timelines.
- Descriptions of country ethics review processes.
- Links to country legislation and guidance documents related to clinical trial ethics.
More information on the database is available on the GHTC’s Breakthroughs blog.
We are continuing to update and expand content on the database and will notify you when further regulatory database updates are available. We welcome any suggestions or comments in regard to existing database content and additional resources that we could include!